UltrasonographyNCT04711031
Focused Lung Ultrasound: A Prospective Cohort Study in General Practice
An observational study of Ultrasonography and Respiratory Tract Infections, run by Aalborg University at 1 site in Denmark.
Trial summary
This is a prospective cohort study that describes focused lung ultrasound (FLUS) findings in patients presenting with symptoms of an acute lower respiratory tract infection (LRTI) in general practice in Denmark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasonography, Respiratory Tract Infections, Pneumonia
- What is being tested?
- FLUS
- How many people
- 91 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 5 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GPs: Eligible GPs who are interested in participating will be identified through our GP network, the Facebook page for Center for General Practice at Aalborg University, the Facebook group Ultralyd i almen praksis I Danmark [Ultrasound in general practice in Denmark] and via our collaboration with the Danish Society for Ultrasound in General Practice (DAUS). Ten GPs will be selected based on demographics, experience with PoCUS, experience with FLUS, organisational aspects of the clinic and number of years as a general practitioner. Patients: Eligible patients will be identified when they present to general practice. Written and oral information about the study will be provided by the GP to all potential participants and if they consent to participate, they will be included.
Who may be able to join
- GPs who use PoCUS (Point-of-Care Ultrasound) at least once a week in general practice or out-of-hour services.
- Patients aged ≥ 18 years with acute cough (< 28 days) and at least one other symptom of an acute LRTI and where the GP suspects CAP.
Who cannot join
- Previous antibiotic prescription for the current episode of acute LRTI.
- Patients not listed with the GP (no medical record available).
- The patient is not capable of understanding and signing informed consent.
- The patient does not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective cohort study that describes focused lung ultrasound (FLUS) findings in patients presenting with symptoms of an acute lower respiratory tract infection (LRTI) in general practice in Denmark.
Ten general practitioners (GPs) will perform FLUS in addition to their usual care of adults presenting with symptoms of an acute LRTI where the GP suspects a community-acquired pneumonia (CAP). Eligible patients will consecutively be invited to participate during a two months' study period until each GP has included a total of ten patients. The GPs will register information about patients including age, gender, symptoms, clinical findings, results of any point-of-care test performed, if antibiotic treatment was prescribed and they will register information on FLUS performance and findings.
- Being tested
- FLUS
- Medical subject headings
- Respiratory Tract Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUSOther
The participating GPs use ultrasonography on a weekly basis and will use the ultrasonography device already available to them; however, the ultrasound machine system and type of transducer will be reported. The GPs will use a 14-zone FLUS scanning protocol that has previously been validated in a general practice setting. Each of the scanning zones on the patient's left side can be denoted from 1L to 7L and from 1R to 7R on the right side. Each scanning zone should be assessed using FLUS. The transducer is placed in the middle of a scanning zone making a cross sectional image of an intercostal space and the underlying pleura blades. The patients will be examined in an upright position. The GPs will be trained in the 14-zone scanning protocol during a FLUS training program prior to recruitment of patients. FLUS pathological findings are predefined, and the variables will be dichotomized into present or not present for each scanning zone.
| Study group | Role | What they receive |
|---|---|---|
| Usual care + FLUS | At index consultation, patients will receive a FLUS examination in addition to the GP's usual care of adults presenting with symptoms of an acute LRTI. Receives: Other: FLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLUS findings
Description of FLUS findings in patients with symptoms of acute LRTI in general practice where the GP suspects CAP.
Measured: 2022
Secondary outcomes (9)
Distribution of FLUS findings
Distribution of FLUS findings in each of the 14 scanning zones.
Measured: 2022
FLUS image quality
Proportion of FLUS examinations with acceptable image quality assessed by expert reviewers.
Measured: 2022
Agreement on FLUS findings
Level of agreement between GPs and expert reviewers on FLUS findings.
Measured: 2022
Unexpected events
Any unexpected events during the FLUS examination.
Measured: 2022
Clinical impact of FLUS
Clinical impact of FLUS on antibiotics prescription, working diagnosis, confidence in working diagnosis, plans for treatment and visitation.
Measured: 2022
FLUS feasibility
Number of patients where FLUS was not performed or only partially completed and the reasons for this. Number of technical breakdowns or ultrasound machine not available.
Measured: 2022
Characteristics of patients
Characteristics of patients including age, gender, symptoms, clinical findings, results of any point-of-care test performed, if antibiotic treatment was prescribed, referral to secondary care for other imaging, examination or treatment.
Measured: 2022
Complications and hospitalisation
Number of reported complications and hospitalisations within 28 days of follow-up. Complications included: Empyema, lung abscess, pleural effusion or sepsis.
Measured: 2022
GP follow-up initiatives
Any GP follow-up initiatives within 28 days of follow-up.
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Mar 2021
- Primary completion5 May 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Jepsen Strøm, Aalborg University
- Investigators
- Julie J Strøm, MD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711031
- Sponsor's protocol ID
- 194-1
- Status last verified
- Aug 2023
- First submitted
- 13 Jan 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Strom JJ, Andersen CA, Jensen MB, Thomsen JL, Laursen CB, Skaarup SH, Schultz HHL, Hansen MP. Evaluating general practitioners' focused lung ultrasound competence and findings in patients with suspected community-acquired pneumonia in general practice. Scand J Prim Health Care. 2025 Jun;43(2):359-369. doi: 10.1080/02813432.2024.2447083. Epub 2024 Dec 30.
PubMed 39736112
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Lung Ultrasound: A Prospective Cohort Study in General Practice
- ClinicalTrials.gov ID
- NCT04711031
- Acronym / sponsor ID
- 194-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective cohort study that describes focused lung ultrasound (FLUS) findings in patients presenting with symptoms of an acute lower respiratory tract infection (LRTI) in general practice in Denmark.
Ten general practitioners (GPs) will perform FLUS in addition to their usual care of adults presenting with symptoms of an acute LRTI where the GP suspects a community-acquired pneumonia (CAP). Eligible patients will consecutively be invited to participate during a two months' study period until each GP has included a total of ten patients. The GPs will register information about patients including age, gender, symptoms, clinical findings, results of any point-of-care test performed, if antibiotic treatment was prescribed and they will register information on FLUS performance and findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual care + FLUS | – | Other: FLUSAt index consultation, patients will receive a FLUS examination in addition to the GP's usual care of adults presenting with symptoms of an acute LRTI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GPs: Eligible GPs who are interested in participating will be identified through our GP network, the Facebook page for Center for General Practice at Aalborg University, the Facebook group Ultralyd i almen praksis I Danmark [Ultrasound in general practice in Denmark] and via our collaboration with the Danish Society for Ultrasound in General Practice (DAUS). Ten GPs will be selected based on demographics, experience with PoCUS, experience with FLUS, organisational aspects of the clinic and number of years as a general practitioner. Patients: Eligible patients will be identified when they present to general practice. Written and oral information about the study will be provided by the GP to all potential participants and if they consent to participate, they will be included.
Key inclusion criteria (2 listed)
- GPs who use PoCUS (Point-of-Care Ultrasound) at least once a week in general practice or out-of-hour services.
- Patients aged ≥ 18 years with acute cough (< 28 days) and at least one other symptom of an acute LRTI and where the GP suspects CAP.
Key exclusion criteria (4 listed)
- Previous antibiotic prescription for the current episode of acute LRTI.
- Patients not listed with the GP (no medical record available).
- The patient is not capable of understanding and signing informed consent.
- The patient does not wish to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLUSThe participating GPs use ultrasonography on a weekly basis and will use the ultrasonography device already available to them; however, the ultrasound machine system and type of transducer will be reported. The GPs will use a 14-zone FLUS scanning protocol that has previously been validated in a general practice setting. Each of the scanning zones on the patient's left side can be denoted from 1L to 7L and from 1R to 7R on the right side. Each scanning zone should be assessed using FLUS. The transducer is placed in the middle of a scanning zone making a cross sectional image of an intercostal space and the underlying pleura blades. The patients will be examined in an upright position. The GPs will be trained in the 14-zone scanning protocol during a FLUS training program prior to recruitment of patients. FLUS pathological findings are predefined, and the variables will be dichotomized into present or not present for each scanning zone. | Other | Usual care + FLUS |
Primary outcome
FLUS findings
Time frame: 2022
Description of FLUS findings in patients with symptoms of acute LRTI in general practice where the GP suspects CAP.
9 secondary outcomes
Distribution of FLUS findings
Time frame: 2022
FLUS image quality
Time frame: 2022
Agreement on FLUS findings
Time frame: 2022
Unexpected events
Time frame: 2022
Clinical impact of FLUS
Time frame: 2022
FLUS feasibility
Time frame: 2022
Characteristics of patients
Time frame: 2022
Complications and hospitalisation
Time frame: 2022
GP follow-up initiatives
Time frame: 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 39736112Strom JJ, Andersen CA, Jensen MB, Thomsen JL, Laursen CB, Skaarup SH, Schultz HHL, Hansen MP. Evaluating general practitioners' focused lung ultrasound competence and findings in patients with suspected community-acquired pneumonia in general practice. Scand J Prim Health Care. 2025 Jun;43(2):359-369. doi: 10.1080/02813432.2024.2447083. Epub 2024 Dec 30.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie J Strøm, MD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography and Respiratory Tract Infections, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLUS findings (time frame: 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04711031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.